DrugPatentWatch Database Preview
ERIVEDGE Drug Profile
» See Plans and Pricing
When do Erivedge patents expire, and when can generic versions of Erivedge launch?
Erivedge is a drug marketed by Genentech and is included in one NDA. There are two patents protecting this drug.
This drug has fifty patent family members in twenty-four countries.
The generic ingredient in ERIVEDGE is vismodegib. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.
US ANDA Litigation and Generic Entry Outlook for Erivedge
Erivedge was eligible for patent challenges on January 30, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 11, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ERIVEDGE
| International Patents: | 50 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 106 |
| Clinical Trials: | 41 |
| Patent Applications: | 70 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ERIVEDGE |
| DailyMed Link: | ERIVEDGE at DailyMed |
Generic Entry Opportunity Date for ERIVEDGE
Generic Entry Date for ERIVEDGE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ERIVEDGE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlaxoSmithKline | Phase 2 |
| Ulrik Lassen | Phase 2 |
| Columbia University | Phase 2 |
Pharmacology for ERIVEDGE
| Drug Class | Hedgehog Pathway Inhibitor |
| Mechanism of Action | Smoothened Receptor Antagonists |
US Patents and Regulatory Information for ERIVEDGE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388-001 | Jan 30, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388-001 | Jan 30, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ERIVEDGE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Luxembourg | 92278 | Start Trial |
| Eurasian Patent Organization | 017262 | Start Trial |
| Ukraine | 96565 | Start Trial |
| Australia | 2013219216 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ERIVEDGE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1789390 | SPC/GB13/060 | United Kingdom | Start Trial | PRODUCT NAME: VISMODEGIB OPTIONALLY IN THE FORM OF A SALT OR SOLVATE; REGISTERED: CH IKS-NO.62497 20130530; UK EU/1/13/848-EMEA/H/C 20130712 |
| 1789390 | C20130027 00083 | Estonia | Start Trial | PRODUCT NAME: VISMODEGIIB;REG NO/DATE: K(2013)4550 (LOPLIK) 12.07.2013 |
| 1789390 | C300614 | Netherlands | Start Trial | PRODUCT NAME: VISMODEGIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/13/848 20130712 |
| 1789390 | PA2013024,C1789390 | Lithuania | Start Trial | PRODUCT NAME: VISMODEGIBUM; REGISTRATION NO/DATE: EU/1/13/848 20130712 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
